El‐Khayat 2015.
Study characteristics | ||
Methods | Methods: randomised controlled trial, 2 groups, set in Kasr Al‐Aini Teaching Hospital at Cairo University and a Middle East IVF Centre, Egypt February 2012 to October 2014 Number of participants randomised: 332 Number of participants analysed: 332 |
|
Participants | Inclusion criteria: women with unexplained infertility or couples with mild male factor infertility; female partner younger than 39 years; regular menstrual cycles; body mass index < 32 kg/m²; normal uterine cavity with normal thin endometrium measuring < 5 mm on Day 4; bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography); normal hormonal profile Exclusion criteria: women diagnosed with infertility due to other causes; significant cardiovascular, pulmonary, renal, neurological, or hepatic problems; presence of ovarian cyst > 2 cm before stimulation; abnormal endometrial cavity due to submucous myoma; endometrial polyp; intrauterine synechia; septate or bicornate uterus Cause of infertility: unexplained infertility, mild male factor |
|
Interventions |
Both groups: ovarian stimulation consisted of clomiphene citrate 100 mg/d from Day 3 to 7, human menopausal gonadotropin 75 IU/d from Day 6 to 8. Transvaginal ultrasound was done on Day 9, and when 2 to 3 follicles with > 18 mm diameter were present, human chorionic gonadotropin trigger of 10,000 IU was administered. Intrauterine insemination (IUI) was performed 36 hours after the trigger Degree of endometrial injury: grasping forceps with teeth Timing of endometrial injury: follicular phase (Day 4 to 7) of the preceding cycle Study length: 1 cycle Type of conception: IUI |
|
Outcomes | Reported in the paper:
|
|
Notes | Funding source: none
Conflicts of interest: "all authors have nothing to disclose" Trial registration: NCT01544426 (retrospectively registered) Author correspondence was undertaken |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer generated random number tables" |
Allocation concealment (selection bias) | Low risk | Quote: "opaque sealed envelopes containing the participants' group allocation" The random allocation was put into envelopes every "24 hours at a location different from the study site and sent to an assigned nurse who opened each envelope just before the office hysteroscopy" Study authors confirmed via correspondence that envelopes were sequentially numbered and revealed that this was a mechanism to help ensure no violation of allocation concealment |
Blinding of participants (performance bias) | Low risk | The paper stated, "the patients were blinded to group allocation" Participants were undergoing either hysteroscopy or hysteroscopy and endometrial injury. Although no anaesthesia or analgesia was used, and participant blinding was not formally tested, the control procedure is likely to simulate the intervention and therefore is likely to have blinded participants to their allocation |
Blinding of personnel (performance bias) | High risk | Study did not report any blinding of personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study did not report blinding of outcome assessors, and it was unlikely; however outcomes were unlikely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four participants from the intervention group and 2 from the control group were lost to follow‐up, and none discontinued interventions. The study reported the number of participants missing, and it was similar between groups. The study authors performed intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | Trial was registered retrospectively. We confirmed with trial authors that pain was not recorded |
Other bias | Low risk | We did not identify any other potential sources of bias |